# K120753: Clarisct

- Pathway: 510(k) (Traditional)
- Applicant: Icrco, Inc.
- Decided: Jul 26, 2012 after 135 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Claris CBCT Computed Tomography X-Ray System is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery. The Claris CBCT accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two-dimensional images and three-dimensional renderings...

Source page: https://510kreport.com/device/K120753
Methodology: https://510kreport.com/methodology